跳至主要内容
临床试验/NCT02967926
NCT02967926已完成3 期

Digital SpyGlass Cholangioscopy Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

Chulalongkorn University0 个研究点目标入组 51 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
51
主要终点
Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal

研究概览

简要总结

This study aim to evaluated the effectiveness of Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal without fluoroscopy

详细描述

Patients This study recruited patients who suspected/confirmed CBDS from clinical manifestation, liver function tests and imaging studies. With CBD sized between 5 and 15 millimeters, which measured from transabdominal ultrasonography (US), computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP) or endoscopic ultrasonography (EUS). The exclusion criteria were history of bile duct surgery, bile duct stricture, bile duct tumors, severe comorbid diseases, unstable vital signs, pregnancy, and coagulopathy. All patients were informed and wrote informed consent for the procedure.

Procedures Non-fluoroscopic CBDS removal was performed by experienced endoscopists, using standard side-viewing duodenoscope. After identified major papilla, the investigators performed bile duct cannulation with guidewire assisted technique. Successful cannulation confirmed by visualized bile aspiration. If the patients had difficult cannulation, double guidewire technique was used. After the successful bile duct cannulation, the investigators performed endoscopic standard sphincterotomy (EST). Precut sphincterotomy was not used in this study. Non fluoroscopic balloon extraction was performed. The balloon was pushed up to hilum then the investigators sweep until suspected complete CBD clearance. After that the investigators used digital SpyGlassTM to confirm the complete clearance of CBDS. If SpyGlassTM showed residual CBD stone, the investigators repeat balloon extraction. If SpyGlassTM showed complete clearance, the investigator proceed to perform final cholangiogram as reference standard for this study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with clinically suspected/confirmed CBDS
  • CBD caliber 5-15 mm

排除标准

  • History of bile duct surgery
  • History of bile duct tumor
  • History of bile duct stricture
  • Severe comorbidity
  • Unstable vital signs
  • Pregnancy
  • Coagulopathy

结局指标

主要结局

Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal

时间窗: 1 year

次要结局

  • Complication rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thanawat Luangsukrerk

Gastrointestinal Endoscopy Excellence Center

Chulalongkorn University

相似试验

Digital SpyGlass Confirmed Common Bile Duct Stones... | 临床试验